UK approval for Apple's ECG could take years

U.K. legal approval for the Apple ECG function can take years. Ben Lovejoy contacted the Regulatory Agency for medicines and healthcare products.

You may need to perform a clinical trial as part of the process to obtain a CE mark for your medical device. You must inform MHRA if you intend to do so at least 60 days before starting your research [providing] some basic information about the research device, the target population, the type of research and the estimated application date.

It turns out that Apple received just one day before the keynote FDA approval. It is likely that Apple has been working with regulatory authorities in the United Kingdom for some time, and that process simply takes longer than here in the US.

: UK approval for Apple's ECG could take years

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